Last month, Kiran Shelat let University of Pennsylvania surgeons replace his failing kidneys with one that they knew would infect him with hepatitis C, a virus that could slowly destroy his liver.
Normally, a kidney infected with hep C would be offered only to transplant patients who already have the disease -- or it would be thrown away.
But the advent of new hep C drugs, with cure rates of 95 percent or more, has led Penn transplant specialists to see infected kidneys as a small but valuable opportunity to expand the pool of organs for which 100,000 Americans are waiting.
Two days after Shelat's transplant, tests confirmed that the Yardley civil engineer was hep C positive. He began a 12-week course of Zepatier, Merck's $55,000 therapy.
Although it is too soon to say Shelat is cured, the virus is now undetectable in his blood, the Penn team announced Tuesday morning. And he is free of peritoneal dialysis, the nightly 10-hour blood-cleansing process that was barely controlling the downward spiral caused by his autoimmune kidney disease.
"Walking from the parking lot to my office was an ordeal," he recalled. "Only after the transplant, when I started feeling better, did I realize how bad I felt before. Now I’m walking. I’m breathing better. I go up and down steps. It’s like being altogether a different person."
David S. Goldberg, a Penn liver transplant specialist, is coleading the pilot study of 10 patients with Penn kidney transplant specialist Peter P. Reese. Since it began in May, at least one other patient, Irma Hendricks of East Stroudsburg, Pa., has received a hep C-positive kidney, then eradicated her resulting infection with Zepatier.
If effective, the new approach could make a dent in the kidney-transplant waiting list, where about 5 percent of patients die each year.
"Last year, about 12,000 people in the U.S. got a deceased donor kidney transplant. There could be, at a minimum, maybe 1,000 more transplants if this is successful," Goldberg said. "That's not an insignificant number of people who get off dialysis and get their lives back."
Patients who are candidates for the Penn trial go through an unusually intensive informed consent process, including an information session that family members are encouraged to attend. Shelat and his wife, Chetana, and daughter Reshma, who is a nurse, were impressed by the thoroughness and frankness of the researchers.
"They said, 'Quite definitely you will get hepatitis C,' " Shelat recalled. "I thought, 'What if I do this, and take a chance, and get into some serious trouble later on?' But as I listened more, and they showed me Zepatier’s [cure] numbers, I saw they were confident. It allowed me to relax."
Although Penn was the trailblazer, Johns Hopkins University last month launched a similar clinical trial. The first of 10 patients has received a transplant, been treated with Zepatier, and now has no detectable virus, said Niraj Desai, director of Hopkins' kidney transplant program.
"We were throwing these kidneys away," Desai said. "Organs from young donors. We’re throwing them away while wait-list patients are dying."
Merck is donating its drug for the trials, but costs are a major concern. Gilead Sciences' hep C drug, Harvoni, costs about $94,000 for a treatment course. That's in addition to the cost of a transplant and medications to prevent organ rejection.
"But a year of dialysis is close to $75,000," Goldberg said. "If people survive three years, studies show a kidney transplant is cost effective."
Kidney recipients also have one of the highest transplant-survival rates, averaging 15 years, he said.
Besides making use of otherwise wasted organs, transplanting hep C-positive kidneys could help mitigate the horror of the growing opioid epidemic, Goldberg and Reese believe. Many people who become addicted to opioid painkillers go on to inject heroin in order to prevent agonizing withdrawal symptoms. Many wind up with hep C because it is easily transmitted among injectors who share syringes.
"It’s a tragedy, obviously, but there has been a huge increase in donors who die of a drug overdose [and are hep C positive]," Goldberg said. "One bit of solace for the family may be that the kidneys could be used."
Shelat, for one, is eager to become a champion of the approach.
"When I feel better, I would love to take part in this effort and spread the word," he said. "If a patient has even the smallest doubt, here I am, the proof. I’m grateful. I’m blessed."